Medical devices for in vitro diagnostics
In vitro studies (Latin “in glass”) are the studies conducted using components of an organism that have been isolated from their usual biological surroundings in order to permit a more detailed or more convenient analysis than can be done with a whole organism.
Laboratory tests performed in vitro relate to haematology, clinical chemistry, immunology, coagulology, enzymology, endocrinology, microbiology, cytology, histology, oncodiagnostics and molecular genetics.
Medical devices for in vitro diagnosis (IVD) include: instruments, apparatus, devices, equipment, materials, reagents, special software.
They are used for medical purposes alone or in combination.
They are intended to be used during in vitro studies of the samples collected from the human body to obtain information on: a physiological or pathological condition; congenital pathology; disposition to a particular clinical condition or disease; compatibility of tissues with a potential recipient; prediction of reactions to therapeutic interventions; choice of therapeutic agents and/or treatment control.